Meet some of the expert presenters from BD, Aspen Research, Intertek, SGS, and more who are bringing innovative and industry-leading content to the 2021 Extractables and Leachables program.
More speakers to be announced soon!
Bryan Katzenmeyer has over 10+ years of experience specializing in mass spectrometry and separation techniques for the characterization of materials, polymers, monomers, and small molecules as well as increasing leadership roles within technical organizations. He currently oversees the Americas Materials Science business marketing segment for Waters Corporation. The Materials Science business market focuses on polymers, fine and specialty chemicals, extractables/leachables, medical device testing, cosmetics and personal care products, fuel/energy, and agrochemicals. Prior to joining Waters, Bryan was an Analytical Group Leader and Senior Scientist at Valspar (now part of Sherwin-Williams). While here he managed the liquid chromatography and mass spectrometry team focused on developing and validating analytical methodologies to characterize extractables and leachables, resins, oligomers, monomers, and other small molecules in packaging coatings for the food and beverage industries. Bryan received his Ph.D. in Polymer/Analytical Chemistry at The University of Akron working under Distinguished Professor Chrys Wesdemiotis. Here, he researched interfacing liquid chromatography and ion mobility separation with multi-dimensional mass spectrometry for the structural characterization of polymeric materials. He also obtained a M.S. in Chemistry from the University of Wisconsin-Madison and a B.S. in Chemistry from Penn State University.
Dr. Dujuan Lu has been leading the extractables and leachables (E&L) team at SGS Fairfield New Jersey site since 2015. She has extensive pharmaceutical industry experience with more than 200 E&L studies on a broad range of container closure systems, including pharmaceutical finished packaging, process equipment (SUS, MUS, etc) and medical devices. Before joining SGS, she was working at Fresenius Kabi, leading E&L projects to support transfusion and infusion medical device and parenteral products. She has more than 10 years of experience on trace analysis by LC/MS and GC/MS.
Dr. Dujuan Lu obtained her PhD in analytical chemistry from the University of Pittsburgh. She has authored more than 10 peer-reviewed journal publications with more than 300 citations. She has more than 20 international conference presentations as invited speakers and technical session chairs. She is serving as an expert reviewer for more than 10 prestigious journals in the field of analytical chemistry and pharmaceutical science.
Dr. Pearson received his B.S. in Chemistry from Montana State University and his M.S. and Ph.D. in Environmental Chemistry from the University of Minnesota’s School of Public Health. Dr. Pearson joined Aspen Research in 1997 from a post-doctoral position at the University of Minnesota. His prior professional experience includes positions as a Research Chemist and Production Superintendent for Celanese Chemical Corporation. Dr. Pearson has extensive experience in gas chromatographic analysis of volatile and semi-volatile compounds, has coordinated many studies of off gassing phenomena at elevated process temperatures, and is an expert at coupling analytical results back to their process chemistry. He is an industry recognized expert in Extractables and Leachables techniques whose studies have been instrumental in assisting risk professionals in providing guidance for companies navigating in various regulatory arenas.
Theodore (Ted) Heise has three decades of experience in regulatory and clinical affairs, and currently serves as Vice President Regulatory and Clinical Services at MED Institute. In this capacity, Dr. Heise leads efforts to develop scientifically robust regulatory and clinical study strategies for the company’s clients: entrepreneurs, consultants and developers bringing new medical products through the complex steps of the development process.
Graduating Magna Cum Laude with a B.S. in chemistry from the University of Nebraska at Omaha, Dr. Heise went on to earn a Ph.D. in analytical chemistry from Iowa State University. He has been a member of the Regulatory Affairs Professionals Society since 1993, and the American Chemical Society since 1988.
For the past 12 years Dr. Heise has been a U.S. delegate to ISO TC 194, the technical committee for international consensus standards that govern biocompatibility testing and clinical investigations of medical devices. He currently serves as convenor of TC 194/WG 14. As convenor, Dr. Heise led the process of re-writing ISO 10993-18 to reflect current best practices in chemical characterization, including evaluation of extractables and leachables.
Bio Coming Soon
Dr. Alan Hendricker has 15 years of experience in extractables and leachables analysis and 25 years of experience with mass spectrometry. He received his undergraduate degree from Ohio University and Ph.D. from the Colorado School of Mines in 1999. He was a co-author on the PQRI Working Group on Leachables and Extractables recommendation “Safety Thresholds and Best Practices for Leachables and Extractables in Orally Inhaled and Nasal Drug Products (OINDPs).” He has been an active member of the PQRI Leachables and Extractables Parenteral Ophthalmic Drug Product (PODP) working group. He has written and presented extensively on extractables and leachables issues. Alan was a member of the Structural Chemistry Group at Magellan Laboratories through its acquisitions by Cardinal Health and subsequent purchase by the Blackstone Group as Catalent Pharma Solutions. Since January of 2014, Alan works at Becton Dickinson (BD) as part of the corporate preclinical development group on extractables and leachables studies for BD devices and products.
Bio Coming Soon
Currently a Staff Scientist with AstraZeneca in the Research Triangle Park (RTP) working on extractables and leachables (E&L). I have been in the field since 2001. I began my E&L career extracting and analyzing flavor compounds from soy protein. In 2005 I began to work with pMDI container closure systems. Currently manage the E&L activities at RTP and support other R&D groups within AstraZeneca. A member of the Materials Working Group within ELSIE and Knowledge Base sub-team I have been supporting the development of an extractables knowledge base. A member of the IPAC-RS Materials working group and involved with defining medical grade plastics and bio-compatibility. I have a Ph.D. in Physics from the University of Wyoming.
Dr Andrew Feilden joined Hall Analytical in November 2019 as the European E&L Strategic Director. He is a technical expert in the field of E&L testing, having been involved in the field of E&L for over 20 years. At Hall he undertakes Commercial, Operational and technical thought leadership activities.
Andrew has presented on the field of extractables and leachables in over 16 countries worldwide. He has written a number of papers and publications and is the inventor of 2 patents.
He has a degree and D Phil from the university of York, is a Fellow of the Royal Society of Chemistry and was a Scientific Advisor to IPAC-RS and ex-co-chair of ELSIE.
Coming Soon
Lee Mia Nagao, Ph.D. advises domestic and international clients in the areas of evaluation and
regulation of pharmaceutical development and manufacturing. She also advises clients on
pharmaceutical packaging and materials issues, pre-clinical toxicology, auditing, current Good
Manufacturing Practices (cGMPs), supply chain issues, drug master files and other regulatory
submissions. Lee has experience with the development of methods and standards requirements for
drug products and the scientific development and regulation of medical countermeasures (vaccines
and therapeutics) for biosecurity applications. She has broad scientific interests and experience, and
represents industry groups before the FDA, Health Canada, EMA, MHRA, CFDA, ANVISA, USP and other regulatory, standards, industry and scientific organizations world-wide.
Diane Paskiet has over twenty-five years of experience in the pharmaceutical industry. She is currently Director of Scientific Affairs at West Pharmaceutical Services where she is involved in science and regulatory programs associated with safety and compatibility of pharmaceutical packaging and delivery systems. Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories. She is Chair of Product Quality Research Institute (PQRI) Development Technical Committee (DTC) and the Extractables and Leachables Parenteral Drug Product Working Group. Diane is also on the faculty of the Parenteral Drug Association Training Institute and a Board Member of Xavier Health Innovation Training Center of Excellence (ITCE). She has author/co-author a number of papers and book chapters related to pharmaceutical packaging, delivery systems and combination products.
Gyorgy Vas has over 20 years of experience in scientific research, product development, and laboratory management. Much of that time has been spent in a cGMP environment, where he has provided his expertise to solve problems related to finished pharmaceutical products and medical devices.
In his current position, he advises on regulatory filing strategies for multiple clients, and his group provides solutions for mitigating deficiency letters. Gyorgy led the implementation of state-of-the-art solventless sample preparation techniques into the cGMP laboratory processes, and is one of the few in this field with expertise in method development and validation for ultratrace (parts-per-trillion) level impurities in finished pharmaceutical products and medical devices.
Dr. Yu has been leading extractables and leachables study since 2003, providing scientific leadership, technical and regulatory guidance to the team members and many clients for the design and execution of extractables/leachables programs. His team have successfully completed hundreds of extractables and leachables studies for numerous drug products, including pMDI, DPI, parenteral, ophthalmic, transdermal and oral dosage forms as well as medical device and drug/device combination products etc.; in the past three years, there are at least 25 drug products approved with extractables and leachables studies completed by Dr. Yu's team.
Born: 10.09.1981 in Piekary Śląskie, Poland
Alicja is currently employed at the Octapharma where she is responsible for material qualification at corporate level including chemical safety assessment of polymerc processing, packaging, and administration materials and the planning and supervision of extractables and leachables studies.
Prior to joining Octapharma, Alicja had a tenured position as a researcher at the French National Institute for Agricultural Research (INRA) where she investigated various possibilities to increase sustainability in the food processing industry. Alicja has compelled broad experience in material and polymer science and technology at the Institute for Composite Materials (IVW) in Kaiserslautern as well as at the Centre for Neutron Science (JCNS) and at the Institute for Nuclear Waste Disposal and Nuclear Safety (IEK-6) at the Research Centre in Jülich, Germany.
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood. Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Mexico and Sweden. For more information visit www.octapharma.com.
